BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 8306562 · Received February 5, 2019

    Report

    Report Number
    3011393376-2019-00512
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 24, 2019
    Report Date
    May 1, 2019
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT AVIVA METERS, WITHIN 10 MINUTES: A RESULT BETWEEN "16.0 MMOL/L TO 18.5 MMOL/L", A RESULT BETWEEN "7.0 MMOL/L TO 8.0 MMOL/L", AND A RESULT BETWEEN "6.0 MMOL/L TO 7.0 MMOL/L". NO ADVERSE EVENT REPORTED. THE SAME TEST STRIP VIAL WAS USED FOR BOTH METERS AND RESULTS. IT IS UNKNOWN WHICH METER DISPLAYED WHICH RESULT. RETURN OF THE SUSPECT DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101195 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 497633

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR